Clearance Summary
HEART 2006 received FDA 510(k) clearance under submission number K032736, sponsored by Aerotel Medical Systems (1998) , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-10-03.
- Submission: K032736
- Applicant / Sponsor: Aerotel Medical Systems (1998) , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2003-10-03
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.